🇪🇺 Ceftolozane-tazobactam IV in European Union

EMA authorised Ceftolozane-tazobactam IV on 18 September 2015

Marketing authorisation

EMA — authorised 18 September 2015

  • Application: EMEA/H/C/003772
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Zerbaxa
  • Indication: Zerbaxa is indicated for the treatment of the following infections in adults: Complicated intra abdominal infections; Acute pyelonephritis; Complicated urinary tract infections; Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: approved

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Ceftolozane-tazobactam IV in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is Ceftolozane-tazobactam IV approved in European Union?

Yes. EMA authorised it on 18 September 2015.

Who is the marketing authorisation holder for Ceftolozane-tazobactam IV in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.